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. 2010 Oct 4;28(34):5046–5053. doi: 10.1200/JCO.2010.29.6608

Table 2.

AEs Detected as Drug Effects in the Analysis of All Patients in the Candidate Studies

Trial Grade 3+ Events Detected in≥ 2% Incidence Difference
AVAiL

  • Weight decreased

  • Proteinuria*

  • Nausea*

  • Vomiting*

  • Asthenia*

  • Peripheral sensory neuropathy*

  • Neutropenia*†

  • Epistaxis†

  • Hypertension*†
AVF2107g

  • Abdominal pain

  • Leukopenia

  • Hypertension*

  • Pain†

  • Deep thrombophlebitis*†

  • Constipation†

  • Diarrhea†
ECOG 4599

  • Febrile neutropenia

  • Infection without neutropenia

  • Hyponatremia

  • Proteinuria*

  • Neutrophils*

  • Fatigue*

  • Headache*

  • Hypertension*
EGF30001

  • Leukopenia

  • Nausea

  • Febrile neutropenia†

  • Neutropenia†

  • Diarrhea*†

  • Hypokalemia*

  • Rash†
JMDB

  • Anorexia*

  • Nausea*
BIG 1-98 No events identified in excess of 2%
CALGB 89803

  • Thrombosis/embolism

  • Hemoglobin*†

  • Leukocytes*†

  • Neutrophils/granulocytes*†

  • Platelets*†

  • Fatigue*†

  • Alopecia*

  • Febrile neutropenia*

  • Infection*
HERA Ejection fraction decreased†
Trial Grade 1 to 2 Events Detected in≥ 5% Incidence Difference
AVAiL

  • Epistaxis*†

  • Fatigue*

  • Headache*

  • Hypertension*†

  • Neutropenia*†

  • Stomatitis*
BIG 1-98 Hypercholesterolemia
CALGB 89803

  • Sweating (diaphoresis)

  • Constipation

  • Hemoglobin*†

  • Leukocytes (total WBC)*†

  • Neutrophils/granulocytes*†

  • Fatigue (lethargy/malaise/asthenia)*†

  • Alopecia*

  • Diarrhea (without colostomy)*†

  • Nausea*†

  • Vomiting*†
HERA

  • Fatigue

  • Headache*

  • Nasopharyngitis*

  • Nausea*

  • Chills*

  • Diarrhea*

  • Pyrexia*

NOTE. Adverse events in italics could be missed under AE subsampling. Trial JMDB was a head-to-head study. Drug signals were determined where the pemetrexed arm had a 2% excess of incidence over the gemcitabine arm. For trial CALGB 89803, serious AEs and AEs leading to dose modifications were not identified as such in the case report forms. The determination of known events from this study was based only on a 2% excess of AEs leading to drug discontinuation or death. For study ECOG 4599, serious AEs and AEs leading to drug discontinuation or dose modifications were not identified as such in the case report forms. Therefore, there was no separate determination of known events from this study.

Abbreviations: AE, adverse event; AVAiL, Avastin in Lung; ECOG, Eastern Cooperative Oncology Group; BIG, Breast International Group; CALGB, Cancer and Leukemia Group B; HERA, HERceptin Adjuvant.

*

Known from previous trials.

†

Identified as known in candidate trial from analysis of AEs to be collected in all patients (see Methods).