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Invirase (Saquinavir) - Side Effect Reports to FDA

 
 



This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Invirase (Saquinavir) and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.

Reports by Event Outcome

All Cases (34)
Death (4)
Life Threatening Events (3)
Disability (3)

Reports by Reaction Type

Hypospadias (7)Maternal Exposure Timing Unspecified (6)Maternal Exposure During Pregnancy (5)Hepatic Function Abnormal (4)Cardiac Failure (4)Pulmonary Hypertension (3)Infection (3)Palpitations (3)Dizziness (3)Penile Curvature (3)Anaemia (3)Neoplasm Malignant (3)

Below are a few examples of reports where side effects / adverse reactions may be related to Invirase (Saquinavir). For a complete list or a specific selection of reports, please use the links above.

Possible Invirase side effects in

Reported by a physician from Japan on 2012-08-27

Patient:

Reactions: Hepatic Function Abnormal, Cardiac Failure

Adverse event resulted in: death, hospitalization

Drug(s) suspected as cause:
Invirase
    Dosage: divided dose requency u
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2006-10-26

Isentress
    Dosage: divided dose frequency unknown
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2008-07-31
    End date: 2011-08-07

Kaletra
    Dosage: divided dose frequency unknown
    Administration route: Oral
    Start date: 2004-08-31
    End date: 2006-09-21

Kaletra
    Dosage: divided dose frequency unknown
    Administration route: Oral
    Start date: 2006-10-26
    End date: 2011-07-07

Kaletra
    Dosage: divided dose frequency unknown
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2002-09-03
    End date: 2004-08-04

Other drugs received by patient: Halcion



Possible Invirase side effects in 24 year old male

Reported by a consumer/non-health professional from United States on 2012-08-21

Patient: 24 year old male

Reactions: Pulmonary Hypertension, Palpitations, Dizziness

Adverse event resulted in: life threatening event, disablity

Drug(s) suspected as cause:
Crixivan
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2000-03-18
    End date: 2000-05-24

Efavirenz
    Dosage: interrupted from 07/25/00 to 09/25/00 24jul-25jul2000,25sep-02oct2000. film coated tab 200 mg
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2000-07-24
    End date: 2000-10-02

Epivir
    Dosage: tabs
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2004-05-15
    End date: 2008-09-19

Invirase
    Dosage: inter:03/18/00-05/24/00,caps 800mg:19jun99-18mar2000.divided dse:24may00-24dec2000,19jun1999-24dc00
    Administration route: Oral
    Indication: HIV Infection
    Start date: 1999-06-19
    End date: 2001-03-31

Kaletra
    Dosage: 1df,25dec2000-24apr2004:1217 days
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2000-12-25
    End date: 2004-04-24

Norvir
    Dosage: 31mar2001(interrupted).caps 800mg:19jun99-31oct-99.divided dose:01nov99-24dec2000.25apr2004
    Administration route: Oral
    Indication: HIV Infection
    Start date: 1999-06-19
    End date: 2008-09-19

Videx
    Dosage: 250,300,400mg12/19/94-3/7/97,3/07/97-7/21/01,7/21/01,125mg,19dc94-7mar97(810d),7mr97-21jl01(1598d)
    Administration route: Oral
    Indication: HIV Infection
    Start date: 1994-12-19
    End date: 2001-07-21

Videx EC
    Dosage: divided dose
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2001-07-21
    End date: 2004-05-14

Zerit
    Dosage: 60 mg 8/25/97-27/2/98, 80 mg 2/27-8/3/98, 11/9/98 -6/19/99 and 12/25/00-10/20/01
    Administration route: Oral
    Indication: HIV Infection
    Start date: 1997-08-25
    End date: 2001-10-20

Ziagen
    Dosage: interrupted from 07/25/00 to 10/20/01 tabs24jul-25jul2000.20oct2001-27oct2001.
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2000-07-24
    End date: 2001-10-27

Other drugs received by patient: Cross Eight M



Possible Invirase side effects in male

Reported by a consumer/non-health professional from United States on 2012-08-10

Patient: male

Reactions: Renal Failure, Neoplasm Malignant, Penile Infection, Penis Carcinoma, Escherichia Infection, Infection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Invirase



Possible Invirase side effects in 31 year old female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-10

Patient: 31 year old female

Reactions: Anaemia

Drug(s) suspected as cause:
Combivir
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2012-03-12

Epzicom
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2012-05-05

Invirase
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2012-03-12

Norvir
    Administration route: Oral
    Indication: Antiretroviral Therapy
    Start date: 2012-03-12



Possible Invirase side effects in female

Reported by a health professional (non-physician/pharmacist) from Russian Federation on 2012-08-08

Patient: female

Reactions: Anaemia, Maternal Exposure During Pregnancy

Drug(s) suspected as cause:
Abacavir Sulfate / Lamivudine
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2012-05-05

Combivir
    Dosage: 1u unknown
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2012-03-12

Invirase
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2012-03-12

Ritonavir
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2012-03-12



Possible Invirase side effects in male

Reported by a consumer/non-health professional from France on 2012-07-13

Patient: male

Reactions: Hypospadias, Maternal Exposure Timing Unspecified

Drug(s) suspected as cause:
Abacavir Sulfate and Lamivudine
    Indication: Product Used FOR Unknown Indication

Emtricitabine and Tenofovir Disoproxil Fumarate
    Indication: Product Used FOR Unknown Indication

Invirase
    Indication: Product Used FOR Unknown Indication

Lopinavir and Ritonavir
    Indication: Product Used FOR Unknown Indication



Possible Invirase side effects in female

Reported by a consumer/non-health professional from France on 2012-07-10

Patient: female

Reactions: Hypospadias, Maternal Exposure Timing Unspecified

Drug(s) suspected as cause:
Abacavir Sulfate and Lamivudine
    Indication: Product Used FOR Unknown Indication

Emtricitabine and Tenofovir Disoproxil Fumarate
    Indication: Product Used FOR Unknown Indication

Invirase
    Indication: Product Used FOR Unknown Indication

Lopinavir and Ritonavir
    Indication: Product Used FOR Unknown Indication



Possible Invirase side effects in male

Reported by a physician from Japan on 2012-07-06

Patient: male

Reactions: Hepatic Function Abnormal, Cardiac Failure

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Didanosine
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2006-10-26

Invirase
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2006-10-26

Lopinavir and Ritonavir
    Administration route: Oral
    Indication: HIV Infection
    End date: 2006-09-21

Lopinavir and Ritonavir
    Administration route: Oral
    Start date: 2006-10-26

Raltegravir
    Administration route: Oral
    Indication: HIV Infection

Other drugs received by patient: Ziagen; Halcion; Viread



Possible Invirase side effects in female

Reported by a health professional (non-physician/pharmacist) from Russian Federation on 2012-07-05

Patient: female

Reactions: Maternal Exposure During Pregnancy, Anaemia

Drug(s) suspected as cause:
Abacavir Sulfate / Lamivudine
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2012-05-05

Combivir
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2012-03-12

Invirase
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2012-03-12

Ritonavir
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2012-03-12



Possible Invirase side effects in

Reported by a health professional (non-physician/pharmacist) from Germany on 2012-06-26

Patient:

Reactions: Hepatic Fibrosis

Drug(s) suspected as cause:
Didanosine
    Indication: HIV Infection

Invirase
    Indication: HIV Infection

Lopinavir
    Indication: HIV Infection

Stavudine
    Indication: HIV Infection

Zalcitabine
    Indication: HIV Infection



Possible Invirase side effects in

Reported by a physician from United States on 2012-06-25

Patient:

Reactions: Fracture

Drug(s) suspected as cause:
Invirase



Possible Invirase side effects in female

Reported by a individual with unspecified qualification from United States on 2012-06-06

Patient: female

Reactions: Neonatal Respiratory Distress Syndrome, Neonatal Tachycardia, Neonatal Tachypnoea, Respiratory Distress, Maternal Exposure Timing Unspecified, Finger Deformity, Trisomy 21, Congenital Eye Disorder, Talipes, Gaze Palsy, Hepatosplenomegaly

Adverse event resulted in: death

Drug(s) suspected as cause:
Invirase



Possible Invirase side effects in male

Reported by a consumer/non-health professional from United States on 2012-06-01

Patient: male

Reactions: Renal Failure, Neoplasm Malignant, Penile Infection, Penis Carcinoma, Escherichia Infection, Infection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Invirase



Possible Invirase side effects in female

Reported by a individual with unspecified qualification from United States on 2012-05-30

Patient: female

Reactions: Maternal Exposure During Pregnancy, Death Neonatal

Adverse event resulted in: death

Drug(s) suspected as cause:
Invirase

Other drugs received by patient: Kaletra; Combivir; Isentress



Possible Invirase side effects in female

Reported by a consumer/non-health professional from United States on 2012-05-29

Patient: female

Reactions: Trisomy 21, Congenital Eye Disorder, Talipes, Respiratory Distress, Maternal Exposure Timing Unspecified, Hepatosplenomegaly, Gaze Palsy, Finger Deformity

Adverse event resulted in: death

Drug(s) suspected as cause:
Invirase



Possible Invirase side effects in male

Reported by a consumer/non-health professional from United States on 2012-05-17

Patient: male

Reactions: Neoplasm Malignant, Infection

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Invirase



Possible Invirase side effects in 48 year old male

Reported by a pharmacist from Germany on 2012-05-15

Patient: 48 year old male

Reactions: Blood Cortisol Decreased, Blood Testosterone Decreased, Blood Oestrogen Decreased, Blood Cholesterol Decreased

Drug(s) suspected as cause:
Invirase

Other drugs received by patient: Kaletra



Possible Invirase side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-04-30

Patient: female, weighing 71.4 kg (157.2 pounds)

Reactions: Hypokalaemia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Blinded Cicletanine
    Administration route: Oral
    Indication: Pulmonary Arterial Hypertension

Invirase
    Indication: HIV Infection

Ritonavir
    Indication: HIV Infection

Other drugs received by patient: Potassium Chloride; Vitamin C; Ambrisentan; Seroquel



Possible Invirase side effects in female

Reported by a health professional (non-physician/pharmacist) from United States on 2012-04-26

Patient: female, weighing 71.4 kg (157.2 pounds)

Reactions: Hypokalaemia

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Cicletanine Hydrochloride
    Administration route: Oral
    Indication: Pulmonary Arterial Hypertension
    Start date: 2010-05-03

Invirase
    Indication: HIV Infection
    Start date: 1996-09-01

Norvir
    Indication: HIV Infection
    Start date: 1996-09-01

Placebo
    Administration route: Oral
    Indication: Pulmonary Arterial Hypertension

Other drugs received by patient: Ascorbic Acid; Seroquel; Multi-Vitamins; Potassium Chloride; Letairis



Possible Invirase side effects in male

Reported by a physician from Japan on 2012-04-18

Patient: male

Reactions: Hepatic Function Abnormal, Cardiac Failure

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Invirase
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2006-10-26

Lopinavir and Ritonavir
    Administration route: Oral
    Indication: HIV Infection

Raltegravir
    Administration route: Oral
    Indication: HIV Infection

Other drugs received by patient: Halcion



Possible Invirase side effects in 46 year old male

Reported by a individual with unspecified qualification from Japan on 2012-04-13

Patient: 46 year old male

Reactions: Blood Alkaline Phosphatase Increased, Hepatic Function Abnormal, Blood Lactate Dehydrogenase Increased, Alanine Aminotransferase Increased, Pericardial Effusion, Gamma-Glutamyltransferase Increased, Cardiac Failure, Aspartate Aminotransferase Increased, Pleural Effusion

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Invirase
    Dosage: 2000 mg/daily/po
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2006-10-26

Isentress
    Dosage: 800 mg/daily/po
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2008-07-31

Kaletra
    Dosage: 4 dose/daily/po
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2006-10-26

Kaletra
    Dosage: 6 dose/daily/po
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2002-09-03
    End date: 2004-08-04

Kaletra
    Dosage: 6 dose/daily/po
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2004-08-31
    End date: 2006-09-21

Other drugs received by patient: Zerit; Halcion; Videx EC



Possible Invirase side effects in

Reported by a individual with unspecified qualification from Italy on 2012-01-02

Patient:

Reactions: Drug Resistance, Treatment Failure

Drug(s) suspected as cause:
Invirase



Possible Invirase side effects in 53 year old female

Reported by a physician from Portugal on 2011-12-30

Patient: 53 year old female

Reactions: Cardiovascular Disorder

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Invirase
    Indication: HIV Infection

Tenofovir
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2006-12-01

Other drugs received by patient: Zerit; Ritonavir



Possible Invirase side effects in

Reported by a health professional (non-physician/pharmacist) from Netherlands on 2011-12-29

Patient:

Reactions: Hyperbilirubinaemia, Rash

Drug(s) suspected as cause:
Emtricitabine and Tenofovir Disoproxil Fumarate
    Indication: HIV Infection

Invirase
    Dosage: 2000/100 mg
    Indication: HIV Infection



Possible Invirase side effects in 24 year old male

Reported by a consumer/non-health professional from United States on 2011-12-07

Patient: 24 year old male

Reactions: Pulmonary Hypertension, Palpitations, Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, Dizziness

Adverse event resulted in: life threatening event, disablity

Drug(s) suspected as cause:
Crixivan
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2000-03-18
    End date: 2000-05-24

Efavirenz
    Dosage: 24-25jul00(2d)-600mg 25sep00-02oct00(8d)
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2000-07-24
    End date: 2000-10-02

Epivir
    Dosage: tab
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2004-05-15
    End date: 2008-09-19

Invirase
    Dosage: caps; 19jun99-18mar00(274d) 24may00-24dec00(215d)800mg
    Administration route: Oral
    Indication: HIV Infection
    Start date: 1999-06-19
    End date: 2000-12-24

Kaletra
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2000-12-25
    End date: 2004-04-24

Norvir
    Dosage: 19jun-31oct99;400mg 01nov99-24dec00;420d 100mg/d 24apr05-19sep08;1244d 200mg/d 20sep08-cont
    Administration route: Oral
    Indication: HIV Infection
    Start date: 1999-06-19

Videx
    Dosage: 19dec94-7mar97(125mg)810d 8mar97-21jul01(300mg)1597d 22jul-14may04(400mg)1028d
    Administration route: Oral
    Indication: HIV Infection
    Start date: 1994-11-19
    End date: 2004-05-14

Zerit
    Dosage: 25aug97-27feb98(187d) 27feb-03aug98(158) 3aug-9nov(99) 9nov98-19jn99(223) 25dc00-20oc01(300d)
    Administration route: Oral
    Indication: HIV Infection
    Start date: 1997-08-25
    End date: 2001-10-20

Ziagen
    Dosage: 24jul-25jul00(2d)600mg 20oct-27oct01(8d)600mg interrupted on 25jul00
    Administration route: Oral
    Start date: 2000-07-24
    End date: 2001-10-27

Other drugs received by patient: Cross Eight M



Possible Invirase side effects in 24 year old male

Reported by a individual with unspecified qualification from Japan on 2011-12-06

Patient: 24 year old male

Reactions: Pulmonary Hypertension, Palpitations, Dizziness, Apparent Life Threatening Event

Adverse event resulted in: life threatening event, disablity

Drug(s) suspected as cause:
Crixivan
    Dosage: 800 mg/daily po
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2000-03-18
    End date: 2000-05-24

Efavirenz
    Dosage: 600 mg/daily po ; 600 mg/daily po
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2000-09-25
    End date: 2000-10-02

Efavirenz
    Dosage: 600 mg/daily po ; 600 mg/daily po
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2000-07-24
    End date: 2000-07-25

Invirase
    Dosage: 400 mg/bid po ; 800 mg/daily po
    Administration route: Oral
    Indication: HIV Infection
    Start date: 1999-06-19
    End date: 2000-03-18

Invirase
    Dosage: 400 mg/bid po ; 800 mg/daily po
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2000-05-24
    End date: 2000-12-24

Kaletra
    Dosage: 6 dose/daily po
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2000-12-25
    End date: 2004-04-24

Lamivudine
    Dosage: 300 mg/daily po
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2004-05-15
    End date: 2008-09-19

Norvir
    Dosage: 400 mg/bid po ; 800 mg/daily po ; 100 mg/daily po ; 200 mg/daily po
    Administration route: Oral
    Indication: HIV Infection
    Start date: 1999-06-19
    End date: 1999-10-31

Norvir
    Dosage: 400 mg/bid po ; 800 mg/daily po ; 100 mg/daily po ; 200 mg/daily po
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2008-09-20

Norvir
    Dosage: 400 mg/bid po ; 800 mg/daily po ; 100 mg/daily po ; 200 mg/daily po
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2005-04-25
    End date: 2008-09-19

Norvir
    Dosage: 400 mg/bid po ; 800 mg/daily po ; 100 mg/daily po ; 200 mg/daily po
    Administration route: Oral
    Indication: HIV Infection
    Start date: 1999-11-01
    End date: 2000-12-24

Videx
    Dosage: 400 mg/daily po
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2001-07-21
    End date: 2004-05-14

Videx
    Dosage: 125 mg/bid po ; 300 mg/daily po
    Administration route: Oral
    Indication: HIV Infection
    Start date: 1994-12-19
    End date: 1997-03-07

Videx
    Dosage: 125 mg/bid po ; 300 mg/daily po
    Administration route: Oral
    Indication: HIV Infection
    Start date: 1997-03-07
    End date: 2001-07-21

Zerit
    Dosage: 30 mg/bid po ; 40 mg/bid po ; 30 mg/bid po ; 40 mg/bid po ; 80 mg/daily po
    Administration route: Oral
    Indication: HIV Infection
    Start date: 1998-02-27
    End date: 1998-08-03

Zerit
    Dosage: 30 mg/bid po ; 40 mg/bid po ; 30 mg/bid po ; 40 mg/bid po ; 80 mg/daily po
    Administration route: Oral
    Indication: HIV Infection
    Start date: 1997-08-25
    End date: 1998-02-27

Zerit
    Dosage: 30 mg/bid po ; 40 mg/bid po ; 30 mg/bid po ; 40 mg/bid po ; 80 mg/daily po
    Administration route: Oral
    Indication: HIV Infection
    Start date: 1998-08-03
    End date: 1998-11-09

Zerit
    Dosage: 30 mg/bid po ; 40 mg/bid po ; 30 mg/bid po ; 40 mg/bid po ; 80 mg/daily po
    Administration route: Oral
    Indication: HIV Infection
    Start date: 1998-11-09
    End date: 1999-06-19

Zerit
    Dosage: 30 mg/bid po ; 40 mg/bid po ; 30 mg/bid po ; 40 mg/bid po ; 80 mg/daily po
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2000-12-25
    End date: 2001-10-20

Ziagen
    Dosage: 600 mg/daily po ; 600 mg/daily po
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2000-07-24
    End date: 2000-07-25

Ziagen
    Dosage: 600 mg/daily po ; 600 mg/daily po
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2001-10-20
    End date: 2001-10-27

Other drugs received by patient: Antihemophilic Factor (Human)



Possible Invirase side effects in 18 year old

Reported by a health professional (non-physician/pharmacist) from United States on 2011-12-06

Patient: 18 year old

Reactions: Hospitalisation

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Invirase



Possible Invirase side effects in 53 year old female

Reported by a individual with unspecified qualification from Portugal on 2011-12-01

Patient: 53 year old female

Reactions: Cardiovascular Disorder

Adverse event resulted in: hospitalization

Drug(s) suspected as cause:
Invirase
    Indication: HIV Infection

Tenofovir
    Administration route: Oral
    Indication: HIV Infection
    Start date: 2006-12-01

Other drugs received by patient: Ritonavir; Zerit



Possible Invirase side effects in female

Reported by a consumer/non-health professional from France on 2011-11-21

Patient: female

Reactions: Maternal Exposure Timing Unspecified, Hypospadias

Drug(s) suspected as cause:
Abacavir Sulfate and Lamivudine
    Indication: Product Used FOR Unknown Indication

Emtricitabine and Tenofovir Disoproxil Fumarate
    Indication: Product Used FOR Unknown Indication

Invirase
    Indication: Product Used FOR Unknown Indication

Lopinavir and Ritonavir
    Indication: Product Used FOR Unknown Indication



Possible Invirase side effects in male

Reported by a consumer/non-health professional from France on 2011-11-11

Patient: male, weighing 1.6 kg (3.4 pounds)

Reactions: Hypospadias, Maternal Exposure Timing Unspecified

Drug(s) suspected as cause:
Abacavir Sulfate and Lamivudine
    Indication: Product Used FOR Unknown Indication

Emtricitabine and Tenofovir Disoproxil Fumarate
    Indication: Product Used FOR Unknown Indication

Invirase
    Indication: Product Used FOR Unknown Indication

Lopinavir and Ritonavir
    Indication: Product Used FOR Unknown Indication

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