This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Paraplatin (Carboplatin) 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 (26)
Death (3)
Life Threatening Events (3)
Disability (1)
Reports by Reaction Type
Interstitial Lung Disease (7),
Off Label Use (6),
Gastrointestinal Perforation (4),
Bone Sarcoma (3),
Abdominal Pain Lower (2),
Acute Myeloid Leukaemia (2),
Glioma (1),
Gastrointestinal Necrosis (1),
Acute Monocytic Leukaemia (1),
Disease Progression (1),
Chest Pain (1),
Malignant Melanoma (1)
Possible Paraplatin side effects in 56 year old male
Reported by a physician from France on 2012-08-22
Patient: 56 year old male
Reactions: Acute Myeloid Leukaemia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Cisplatin
Dosage: total dose:456mg
Indication: Lung Adenocarcinoma
Start date: 2005-02-04
End date: 2005-03-24
Gemzar
Dosage: formulation-gemzar 1000 mg powder for sol for inf total dose:11.826mg
Indication: Lung Adenocarcinoma
Start date: 2005-02-04
End date: 2005-04-01
Paraplatin
Dosage: formulation-paraplatine powder for sol for inj total dose:1.064mg
Indication: Lung Adenocarcinoma
Start date: 2005-06-13
End date: 2005-07-04
Paxene
Dosage: paxene 6mg/ml solution for inf total dose:746mg
Indication: Lung Adenocarcinoma
Start date: 2005-06-13
End date: 2005-07-04
Other drugs received by patient: Foradil; Fluticasone Propionate / Salmeterol; Acetaminophen
Possible Paraplatin side effects in
Reported by a physician from United States on 2012-08-08
Patient:
Reactions: Off Label Use, Glioma
Drug(s) suspected as cause:
Etoposide
Dosage: monthly cycle of 5 mg/kg daily for 2 days or 6 mg/kg daily for 2 days. total 6 cycles
Indication: Retinoblastoma
Paraplatin
Dosage: 18.6 mg/kg once or 14 mg/kg daily x 2 days, monthly cycle. total 6 cycles
Indication: Retinoblastoma
Vincristine
Dosage: 0.05 mg/kg once. monthly cycle. received total 6 cycles
Indication: Retinoblastoma
Possible Paraplatin side effects in
Reported by a physician from United States on 2012-08-08
Patient:
Reactions: Off Label Use, Bone Sarcoma
Drug(s) suspected as cause:
Etoposide
Dosage: monthly cycle of 5 mg/kg daily for 2 days or 6 mg/kg daily for 2 days. total 6 cycles
Indication: Retinoblastoma
Paraplatin
Dosage: 18.6 mg/kg once or 14 mg/kg daily x 2 days, monthly cycle. total 6 cycles
Indication: Retinoblastoma
Vincristine
Dosage: 0.05 mg/kg once. monthly cycle. received total 6 cycles
Indication: Retinoblastoma
Possible Paraplatin side effects in
Reported by a physician from United States on 2012-08-08
Patient:
Reactions: Off Label Use, Bone Sarcoma
Adverse event resulted in: death
Drug(s) suspected as cause:
Etoposide
Dosage: monthly cycle of 5 mg/kg daily for 2 days or 6 mg/kg daily for 2 days. total 6 cycles
Indication: Retinoblastoma
Paraplatin
Dosage: 18.6 mg/kg once or 14 mg/kg daily x 2 days, monthly cycle. total 6 cycles
Indication: Retinoblastoma
Vincristine
Dosage: 0.05 mg/kg once. monthly cycle. received total 6 cycles
Indication: Retinoblastoma
Possible Paraplatin side effects in
Reported by a physician from United States on 2012-08-08
Patient:
Reactions: Off Label Use, Acute Promyelocytic Leukaemia
Drug(s) suspected as cause:
Etoposide
Dosage: monthly cycle of 5 mg/kg daily for 2 days or 6 mg/kg daily for 2 days. total 6 cycles
Indication: Retinoblastoma
Paraplatin
Dosage: 18.6 mg/kg once or 14 mg/kg daily x 2 days, monthly cycle. total 6 cycles
Indication: Retinoblastoma
Vincristine
Dosage: 0.05 mg/kg once. monthly cycle. received total 6 cycles
Indication: Retinoblastoma
Possible Paraplatin side effects in
Reported by a physician from United States on 2012-08-08
Patient:
Reactions: Off Label Use, Bone Sarcoma
Drug(s) suspected as cause:
Etoposide
Dosage: monthly cycle of 5 mg/kg daily for 2 days or 6 mg/kg daily for 2 days. total 6 cycles
Indication: Retinoblastoma
Paraplatin
Dosage: 18.6 mg/kg once or 14 mg/kg daily x 2 days, monthly cycle. total 6 cycles
Indication: Retinoblastoma
Vincristine
Dosage: 0.05 mg/kg once. monthly cycle. received total 6 cycles
Indication: Retinoblastoma
Possible Paraplatin side effects in
Reported by a physician from United States on 2012-08-08
Patient:
Reactions: Off Label Use, Malignant Melanoma, Rhabdomyosarcoma
Drug(s) suspected as cause:
Etoposide
Dosage: monthly cycle of 5 mg/kg daily for 2 days or 6 mg/kg daily for 2 days. total 6 cycles
Indication: Retinoblastoma
Paraplatin
Dosage: 18.6 mg/kg once or 14 mg/kg daily x 2 days, monthly cycle. total 6 cycles
Indication: Retinoblastoma
Vincristine
Dosage: 0.05 mg/kg once. monthly cycle. received total 6 cycles
Indication: Retinoblastoma
Possible Paraplatin side effects in 49 year old female
Reported by a consumer/non-health professional from United States on 2012-08-06
Patient: 49 year old female, weighing 57.0 kg (125.4 pounds)
Reactions: Soft Tissue Infection, Dyspnoea, Chest Pain, Anaemia, Platelet Count Decreased, Muscular Weakness, Neutrophil Count Decreased
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Cetuximab
Dosage: 30jan12-12mar12 43 days,26mar12-unk
Indication: Head and Neck Cancer
Start date: 2012-01-30
Paraplatin
Dosage: 30jan12-12mar12 43 days,26mar12-unk 3.75 auc
Indication: Head and Neck Cancer
Start date: 2012-01-30
Pemetrexed Disodium
Dosage: 30jan12-12mar12 500mg/m2,26mar12-unk 375mg/m2
Indication: Head and Neck Cancer
Start date: 2012-01-30
Other drugs received by patient: Vitamin B-12; Folic Acid; Panthenol; Ensure; Fluticasone Propionate; Miralax; Ventolin
Possible Paraplatin side effects in 71 year old female
Reported by a consumer/non-health professional from Japan on 2012-06-26
Patient: 71 year old female, weighing 75.0 kg (165.0 pounds)
Reactions: Acute Monocytic Leukaemia
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Cyclophosphamide
Dosage: twice every 3 weeks x 4 courses
Indication: Breast Cancer
Start date: 2010-09-22
End date: 2010-11-25
Epirubicin
Dosage: twice every 3 weeks x 4 courses
Indication: Breast Cancer
Start date: 2010-09-22
End date: 2010-11-25
Fluorouracil
Dosage: twice every 3 weeks x 4 courses
Indication: Breast Cancer
Start date: 2010-09-22
End date: 2010-11-25
Paclitaxel
Dosage: weekly x 12 courses
Indication: Breast Cancer
Start date: 2010-06-30
End date: 2010-09-15
Paraplatin
Dosage: auc 5 every 3 weeks x 4 courses
Indication: Breast Cancer
Start date: 2010-06-30
End date: 2010-09-15
Possible Paraplatin side effects in 71 year old male
Reported by a consumer/non-health professional from Japan on 2012-03-01
Patient: 71 year old male
Reactions: Interstitial Lung Disease
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Paraplatin
Indication: Lung Squamous Cell Carcinoma Stage Unspecified
Start date: 2012-02-16
End date: 2012-02-16
TS-1
Administration route: Oral
Start date: 2012-02-16
End date: 2012-02-18
Possible Paraplatin side effects in 76 year old male
Reported by a physician from Japan on 2012-02-23
Patient: 76 year old male
Reactions: Lung Disorder, Neoplasm Malignant, Interstitial Lung Disease
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Paraplatin
Indication: Lung Squamous Cell Carcinoma Stage Unspecified
Start date: 2011-08-31
End date: 2011-12-01
TS-1
Administration route: Oral
Indication: Lung Squamous Cell Carcinoma Stage Unspecified
Start date: 2011-08-31
End date: 2012-01-18
Possible Paraplatin side effects in male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-02-20
Patient: male, weighing 59.7 kg (131.2 pounds)
Reactions: Disease Progression
Adverse event resulted in: death, disablity
Drug(s) suspected as cause:
Avastin
Indication: non-Small Cell Lung Cancer
Start date: 2007-02-21
End date: 2007-06-06
Avastin
Start date: 2007-07-13
End date: 2007-09-27
Gemzar
Indication: non-Small Cell Lung Cancer
Start date: 2007-09-27
End date: 2007-09-27
Paraplatin
Indication: non-Small Cell Lung Cancer
Start date: 2007-02-07
End date: 2007-08-23
Taxotere
Indication: non-Small Cell Lung Cancer
Start date: 2007-02-07
End date: 2007-08-23
Other drugs received by patient: Duragesic-100; Duragesic-100; Morphine Sulfate; Duragesic-100; Morphine Sulfate; Duragesic-100; Ativan
Possible Paraplatin side effects in 72 year old female
Reported by a physician from Japan on 2012-01-16
Patient: 72 year old female, weighing 40.0 kg (88.0 pounds)
Reactions: Gastrointestinal Perforation, Abdominal Pain Lower
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Paraplatin
Dosage: freq:other auc:6
Indication: Ovarian Cancer
Start date: 2011-08-30
End date: 2011-09-27
Taxol
Dosage: 180mg/m2:224 mg on 30aug11 stopped on 27sep11 freq:other.
Indication: Ovarian Cancer
Possible Paraplatin side effects in 78 year old male
Reported by a consumer/non-health professional from Japan on 2012-01-13
Patient: 78 year old male
Reactions: Duodenal Perforation
Drug(s) suspected as cause:
Paraplatin
Possible Paraplatin side effects in 72 year old female
Reported by a consumer/non-health professional from Japan on 2012-01-02
Patient: 72 year old female, weighing 40.0 kg (88.0 pounds)
Reactions: Abdominal Pain Lower, Gastrointestinal Perforation
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Paraplatin
Dosage: freq:other auc:6
Indication: Ovarian Cancer
Start date: 2011-08-30
End date: 2011-09-27
Taxol
Dosage: 180mg/m2:224 mg on 30aug11 stopped on 27sep11 freq:other.
Indication: Ovarian Cancer
Possible Paraplatin side effects in
Reported by a consumer/non-health professional from Japan on 2011-12-23
Patient:
Reactions: Interstitial Lung Disease
Drug(s) suspected as cause:
Paraplatin
Indication: non-Small Cell Lung Cancer
Taxol
Indication: non-Small Cell Lung Cancer
Possible Paraplatin side effects in
Reported by a consumer/non-health professional from Japan on 2011-12-23
Patient:
Reactions: Interstitial Lung Disease
Drug(s) suspected as cause:
Paraplatin
Indication: non-Small Cell Lung Cancer
Taxol
Indication: non-Small Cell Lung Cancer
Possible Paraplatin side effects in
Reported by a consumer/non-health professional from Japan on 2011-12-23
Patient:
Reactions: Interstitial Lung Disease
Drug(s) suspected as cause:
Paraplatin
Indication: non-Small Cell Lung Cancer
Taxol
Indication: non-Small Cell Lung Cancer
Possible Paraplatin side effects in
Reported by a consumer/non-health professional from Japan on 2011-12-23
Patient:
Reactions: Interstitial Lung Disease
Drug(s) suspected as cause:
Paraplatin
Indication: non-Small Cell Lung Cancer
Taxol
Indication: non-Small Cell Lung Cancer
Possible Paraplatin side effects in
Reported by a consumer/non-health professional from Japan on 2011-12-23
Patient:
Reactions: Interstitial Lung Disease
Drug(s) suspected as cause:
Paraplatin
Indication: non-Small Cell Lung Cancer
Taxol
Indication: non-Small Cell Lung Cancer
Possible Paraplatin side effects in 71 year old female
Reported by a physician from Japan on 2011-11-24
Patient: 71 year old female
Reactions: Gastrointestinal Necrosis
Adverse event resulted in: death
Drug(s) suspected as cause:
Paraplatin
Indication: Fallopian Tube Cancer
Start date: 2011-10-18
Taxol
Indication: Fallopian Tube Cancer
Start date: 2011-10-18
Possible Paraplatin side effects in female
Reported by a health professional (non-physician/pharmacist) from Japan on 2011-11-21
Patient: female
Reactions: Acute Myeloid Leukaemia
Drug(s) suspected as cause:
Gefitinib
Indication: Lung Adenocarcinoma
Start date: 2008-07-01
Paclitaxel
Indication: Lung Adenocarcinoma
Paraplatin
Indication: Lung Adenocarcinoma
Tegafur + Uracil
Indication: Lung Adenocarcinoma
Vinorelbine
Indication: Lung Adenocarcinoma
Possible Paraplatin side effects in 68 year old female
Reported by a consumer/non-health professional from Japan on 2011-11-16
Patient: 68 year old female
Reactions: Renal Impairment, Skin Disorder
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Paraplatin
Indication: Ovarian Cancer
Start date: 2011-11-04
End date: 2011-11-04
Taxol
Dosage: route :div
Indication: Ovarian Cancer
Start date: 2011-11-04
End date: 2011-11-04
Possible Paraplatin side effects in 72 year old female
Reported by a physician from Japan on 2011-11-03
Patient: 72 year old female
Reactions: Gastrointestinal Perforation
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Paraplatin
Indication: Ovarian Cancer
Taxol
Indication: Ovarian Cancer
Possible Paraplatin side effects in 72 year old female
Reported by a consumer/non-health professional from Japan on 2011-10-28
Patient: 72 year old female
Reactions: Gastrointestinal Perforation
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Paraplatin
Indication: Ovarian Cancer
Taxol
Indication: Ovarian Cancer
Possible Paraplatin side effects in 68 year old male
Reported by a physician from Japan on 2011-10-07
Patient: 68 year old male, weighing 57.5 kg (126.5 pounds)
Reactions: Encephalitis Viral
Drug(s) suspected as cause:
Cyclosporine
Dosage: 350 mg/m2 x 1/4 week
Indication: Adult T-Cell Lymphoma / Leukaemia
Start date: 2011-04-25
End date: 2011-07-05
Cytarabine
Dosage: 40 mg x 1/8 week
Indication: Adult T-Cell Lymphoma / Leukaemia
Start date: 2011-05-31
Doxorubicin Hydrochloride
Dosage: 40 mg/m2 x 1/4week
Indication: Adult T-Cell Lymphoma / Leukaemia
Start date: 2011-04-25
End date: 2011-07-05
Doxorubicin Hydrochloride
Dosage: 30 mg/m2 x 1/4week
Start date: 2011-05-02
End date: 2011-07-12
Etoposide
Dosage: 100 mg/m2 x 1/4 week
Indication: Adult T-Cell Lymphoma / Leukaemia
Start date: 2011-05-09
End date: 2011-07-28
Fildesin
Dosage: 2.4 mg/m2 x 1/4 week
Indication: Adult T-Cell Lymphoma / Leukaemia
Start date: 2011-05-09
End date: 2011-07-28
KW-0761
Dosage: 1.0 mg/kg x 1/2 week
Indication: Adult T-Cell Lymphoma / Leukaemia
Start date: 2011-04-26
End date: 2011-07-27
Methotrexate Sodium
Dosage: 15 mg x 1/8 week
Indication: Adult T-Cell Lymphoma / Leukaemia
Start date: 2011-05-31
Paraplatin
Dosage: 250 mg/m2 x 1/4 week
Indication: Adult T-Cell Lymphoma / Leukaemia
Start date: 2011-05-09
End date: 2011-07-28
Prednisolone
Dosage: 40 mg/m2 x 1/4 week
Administration route: Oral
Indication: Adult T-Cell Lymphoma / Leukaemia
Start date: 2011-04-25
End date: 2011-07-05
Prednisolone
Dosage: 40 mg/m2 x 1/4 week
Administration route: Oral
Start date: 2011-05-09
End date: 2011-07-28
Prednisolone
Dosage: 40 mg/m2 x 1/4 week
Administration route: Oral
Start date: 2011-05-02
End date: 2011-07-12
Prednisolone
Dosage: 15 mg, unk
Administration route: Oral
Indication: Rash
Start date: 2011-08-18
Prednisolone Sodium Succinate INJ
Dosage: 10 mg x 1/8 week
Indication: Adult T-Cell Lymphoma / Leukaemia
Start date: 2011-05-31
Ranimustine
Dosage: 60 mg/m2 x 1/4 week
Indication: Adult T-Cell Lymphoma / Leukaemia
Start date: 2011-05-02
End date: 2011-07-12
Vincristine Sulfate
Dosage: 1 mg/m2 x 1/4 week
Indication: Adult T-Cell Lymphoma / Leukaemia
Start date: 2011-04-25
End date: 2011-07-05
Other drugs received by patient: Diflucan; Gluconsan K; Magmitt; Pursennid; Epinastine Hydrochloride; Myser; Targocid; Hicee; Aspirin; Ketoprofen; Adona; Omeprazole; Sulfamethoxazole; Maxipime; Lendormin; Posterisan; Slow-K
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