NCT01057589 · ADVERSE EVENTS
Adverse events
Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.
Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.
- Collection time frame
- Not reported
- Other-event reporting threshold
- 5%
| Safety group | Serious events | Other events | Deaths |
|---|---|---|---|
| Pemetrexed Cisplatin Cetuximab | 45 / 66 | 65 / 66 | Not reported / Not reported |
Serious adverse events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 12.0
- stats
- group Id
- EG000
- num Affected
- 4
- num At Risk
- 66
- num Events
- 7
- term
- Anaemia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 12.0
- stats
- group Id
- EG000
- num Affected
- 3
- num At Risk
- 66
- num Events
- 3
- term
- Febrile neutropenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 12.0
- stats
- group Id
- EG000
- num Affected
- 3
- num At Risk
- 66
- num Events
- 6
- term
- Leukopenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 12.0
- stats
- group Id
- EG000
- num Affected
- 3
- num At Risk
- 66
- num Events
- 5
- term
- Neutropenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 12.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 66
- num Events
- 1
- term
- Thrombocytopenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA 12.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 66
- num Events
- 1
- term
- Cardio-respiratory arrest
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Congenital, familial and genetic disorders
- source Vocabulary
- MedDRA 12.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 66
- num Events
- 1
- term
- Fanconi syndrome
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA 12.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 66
- num Events
- 1
- term
- Constipation
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA 12.0
- stats
- group Id
- EG000
- num Affected
- 4
- num At Risk
- 66
- num Events
- 5
- term
- Diarrhoea
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA 12.0
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 66
- num Events
- 2
- term
- Dysphagia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA 12.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 66
- num Events
- 1
- term
- Large intestine perforation
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA 12.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 66
- num Events
- 1
- term
- Nausea
Other reported adverse events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 12.0
- stats
- group Id
- EG000
- num Affected
- 26
- num At Risk
- 66
- num Events
- 30
- term
- Anaemia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 12.0
- stats
- group Id
- EG000
- num Affected
- 26
- num At Risk
- 66
- num Events
- 36
- term
- Leukopenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 12.0
- stats
- group Id
- EG000
- num Affected
- 26
- num At Risk
- 66
- num Events
- 35
- term
- Neutropenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 12.0
- stats
- group Id
- EG000
- num Affected
- 16
- num At Risk
- 66
- num Events
- 19
- term
- Thrombocytopenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Eye disorders
- source Vocabulary
- MedDRA 12.0
- stats
- group Id
- EG000
- num Affected
- 6
- num At Risk
- 66
- num Events
- 7
- term
- Conjunctivitis
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Eye disorders
- source Vocabulary
- MedDRA 12.0
- stats
- group Id
- EG000
- num Affected
- 4
- num At Risk
- 66
- num Events
- 5
- term
- Lacrimation increased
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA 12.0
- stats
- group Id
- EG000
- num Affected
- 4
- num At Risk
- 66
- num Events
- 6
- term
- Abdominal pain
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA 12.0
- stats
- group Id
- EG000
- num Affected
- 7
- num At Risk
- 66
- num Events
- 7
- term
- Abdominal pain upper
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA 12.0
- stats
- group Id
- EG000
- num Affected
- 25
- num At Risk
- 66
- num Events
- 29
- term
- Constipation
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA 12.0
- stats
- group Id
- EG000
- num Affected
- 20
- num At Risk
- 66
- num Events
- 28
- term
- Diarrhoea
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA 12.0
- stats
- group Id
- EG000
- num Affected
- 10
- num At Risk
- 66
- num Events
- 11
- term
- Dyspepsia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA 12.0
- stats
- group Id
- EG000
- num Affected
- 12
- num At Risk
- 66
- num Events
- 13
- term
- Dysphagia
Complete source fields
- event Groups
- description
- Pemetrexed 500 mg/m\^2 administered by IV infusion followed by cisplatin 75 mg/m\^2 administered by IV infusion both given on Day 1 of each 21 day cycle. Cetuximab 400 mg/m\^2 administered by IV infusion initially as a loading dose in Week 1, subsequent weeks cetuximab 250 mg/m\^2 administered by IV infusion once per week for a maximum of six 21 day cycles. At the discretion of the investigator participants who completed at least 4 cycles of triplet combination therapy could continue to receive pemetrexed plus cetuximab in the maintenance setting or as a monotherapy of pemetrexed or cetuximab alone in the absence of PD, unacceptable toxicity or any other withdrawal criterion up to 19 months. Participants also received Folic Acid and Vitamin B12 as standard of care dietary supplements.
- id
- EG000
- other Num Affected
- 65
- other Num At Risk
- 66
- serious Num Affected
- 45
- serious Num At Risk
- 66
- title
- Pemetrexed Cisplatin Cetuximab
- frequency Threshold
- 5
- other Events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 12.0
- stats
- group Id
- EG000
- num Affected
- 26
- num At Risk
- 66
- num Events
- 30
- term
- Anaemia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 12.0
- stats
- group Id
- EG000
- num Affected
- 26
- num At Risk
- 66
- num Events
- 36
- term
- Leukopenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 12.0
- stats
- group Id
- EG000
- num Affected
- 26
- num At Risk
- 66
- num Events
- 35
- term
- Neutropenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 12.0
- stats
- group Id
- EG000
- num Affected
- 16
- num At Risk
- 66
- num Events
- 19
- term
- Thrombocytopenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Eye disorders
- source Vocabulary
- MedDRA 12.0
- stats
- group Id
- EG000
- num Affected
- 6
- num At Risk
- 66
- num Events
- 7
- term
- Conjunctivitis
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Eye disorders
- source Vocabulary
- MedDRA 12.0
- stats
- group Id
- EG000
- num Affected
- 4
- num At Risk
- 66
- num Events
- 5
- term
- Lacrimation increased
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA 12.0
- stats
- group Id
- EG000
- num Affected
- 4
- num At Risk
- 66
- num Events
- 6
- term
- Abdominal pain
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA 12.0
- stats
- group Id
- EG000
- num Affected
- 7
- num At Risk
- 66
- num Events
- 7
- term
- Abdominal pain upper
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA 12.0
- stats
- group Id
- EG000
- num Affected
- 25
- num At Risk
- 66
- num Events
- 29
- term
- Constipation
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA 12.0
- stats
- group Id
- EG000
- num Affected
- 20
- num At Risk
- 66
- num Events
- 28
- term
- Diarrhoea
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA 12.0
- stats
- group Id
- EG000
- num Affected
- 10
- num At Risk
- 66
- num Events
- 11
- term
- Dyspepsia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA 12.0
- stats
- group Id
- EG000
- num Affected
- 12
- num At Risk
- 66
- num Events
- 13
- term
- Dysphagia
- serious Events
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 12.0
- stats
- group Id
- EG000
- num Affected
- 4
- num At Risk
- 66
- num Events
- 7
- term
- Anaemia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 12.0
- stats
- group Id
- EG000
- num Affected
- 3
- num At Risk
- 66
- num Events
- 3
- term
- Febrile neutropenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 12.0
- stats
- group Id
- EG000
- num Affected
- 3
- num At Risk
- 66
- num Events
- 6
- term
- Leukopenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 12.0
- stats
- group Id
- EG000
- num Affected
- 3
- num At Risk
- 66
- num Events
- 5
- term
- Neutropenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Blood and lymphatic system disorders
- source Vocabulary
- MedDRA 12.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 66
- num Events
- 1
- term
- Thrombocytopenia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Cardiac disorders
- source Vocabulary
- MedDRA 12.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 66
- num Events
- 1
- term
- Cardio-respiratory arrest
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Congenital, familial and genetic disorders
- source Vocabulary
- MedDRA 12.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 66
- num Events
- 1
- term
- Fanconi syndrome
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA 12.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 66
- num Events
- 1
- term
- Constipation
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA 12.0
- stats
- group Id
- EG000
- num Affected
- 4
- num At Risk
- 66
- num Events
- 5
- term
- Diarrhoea
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA 12.0
- stats
- group Id
- EG000
- num Affected
- 2
- num At Risk
- 66
- num Events
- 2
- term
- Dysphagia
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA 12.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 66
- num Events
- 1
- term
- Large intestine perforation
- assessment Type
- SYSTEMATIC_ASSESSMENT
- organ System
- Gastrointestinal disorders
- source Vocabulary
- MedDRA 12.0
- stats
- group Id
- EG000
- num Affected
- 1
- num At Risk
- 66
- num Events
- 1
- term
- Nausea
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