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NCT02122185 · ADVERSE EVENTS

Adverse events

Metformin and Chemotherapy in Treating Patients With Stage III-IV Ovarian, Fallopian Tube, or Primary Peritoneal Cancer · Source last updated 2026-03-27

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
6 years
Other-event reporting threshold
5%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Metformin Plus Chemotherapy

Patients receive metformin hydrochloride PO BID and standard chemotherapy for 6 -8 cycles. Treatment with metformin hydrochloride continues for up to 2 years in the absence of disease progression or unacceptable toxicity. metformin hydrochloride: Given PO Chemotherapy: Participants will receive standard chemotherapy (6-8 cycles). Specific regimen to be given was chosen from among six protocol-specified options at the discretion of their treating physician.

19 / 5452 / 5431 / 54
Placebo Plus Chemotherapy

Patients receive placebo PO BID and standard chemotherapy for 6 -8 cycles. Treatment with placebo continues for up to 2 years in the absence of disease progression or unacceptable toxicity. placebo: Given PO Chemotherapy: Participants will receive standard chemotherapy (6-8 cycles). Specific regimen to be given was chosen from among six protocol-specified options at the discretion of their treating physician.

13 / 5454 / 5423 / 54

Group identifiers: EG000: Metformin Plus Chemotherapy · EG001: Placebo Plus Chemotherapy

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    NCI CTC Version 4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      54
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      54
    term
    Abdominal infection
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    NCI CTC Version 4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      54
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      54
    term
    Allergic reaction
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    NCI CTC Version 4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      54
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      54
    term
    Anemia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    NCI CTC Version 4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      54
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      54
    term
    Anorexia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    NCI CTC Version 4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      54
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      54
    term
    Chest wall pain
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    NCI CTC Version 4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      54
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      54
    term
    Confusion
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    NCI CTC Version 4.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      54
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      54
    term
    Dehydration
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NCI CTC Version 4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      54
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      54
    term
    Diarrhea
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    NCI CTC Version 4.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      54
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      54
    term
    Dyspnea
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    NCI CTC Version 4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      54
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      54
    term
    Fatigue
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    NCI CTC Version 4.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      54
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      54
    term
    Febrile neutropenia
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    NCI CTC Version 4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      54
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      54
    term
    Generalized muscle weakness

Other reported adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    NCI CTC Version 4.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      54
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      54
    term
    Alanine aminotransferase (ALT) increased
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    NCI CTC Version 4.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      54
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      54
    term
    Alkaline phosphatase increased
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    NCI CTC Version 4.0
    stats
    1. group Id
      EG000
      num Affected
      35
      num At Risk
      54
    2. group Id
      EG001
      num Affected
      42
      num At Risk
      54
    term
    Alopecia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    NCI CTC Version 4.0
    stats
    1. group Id
      EG000
      num Affected
      41
      num At Risk
      54
    2. group Id
      EG001
      num Affected
      44
      num At Risk
      54
    term
    Anemia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    NCI CTC Version 4.0
    stats
    1. group Id
      EG000
      num Affected
      27
      num At Risk
      54
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      54
    term
    Anorexia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    NCI CTC Version 4.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      54
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      54
    term
    Anxiety
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    NCI CTC Version 4.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      54
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      54
    term
    Arthralgia
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    NCI CTC Version 4.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      54
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      54
    term
    Aspartate aminotransferase increased
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    NCI CTC Version 4.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      54
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      54
    term
    Back pain
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    NCI CTC Version 4.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      54
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      54
    term
    Blurred vision
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    NCI CTC Version 4.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      54
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      54
    term
    Cough
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    NCI CTC Version 4.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      54
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      54
    term
    Cystitis noninfective
Complete source fields
event Groups
  1. deaths Num Affected
    31
    deaths Num At Risk
    54
    description
    Patients receive metformin hydrochloride PO BID and standard chemotherapy for 6 -8 cycles. Treatment with metformin hydrochloride continues for up to 2 years in the absence of disease progression or unacceptable toxicity. metformin hydrochloride: Given PO Chemotherapy: Participants will receive standard chemotherapy (6-8 cycles). Specific regimen to be given was chosen from among six protocol-specified options at the discretion of their treating physician.
    id
    EG000
    other Num Affected
    52
    other Num At Risk
    54
    serious Num Affected
    19
    serious Num At Risk
    54
    title
    Metformin Plus Chemotherapy
  2. deaths Num Affected
    23
    deaths Num At Risk
    54
    description
    Patients receive placebo PO BID and standard chemotherapy for 6 -8 cycles. Treatment with placebo continues for up to 2 years in the absence of disease progression or unacceptable toxicity. placebo: Given PO Chemotherapy: Participants will receive standard chemotherapy (6-8 cycles). Specific regimen to be given was chosen from among six protocol-specified options at the discretion of their treating physician.
    id
    EG001
    other Num Affected
    54
    other Num At Risk
    54
    serious Num Affected
    13
    serious Num At Risk
    54
    title
    Placebo Plus Chemotherapy
frequency Threshold
5
other Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    NCI CTC Version 4.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      54
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      54
    term
    Alanine aminotransferase (ALT) increased
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    NCI CTC Version 4.0
    stats
    1. group Id
      EG000
      num Affected
      4
      num At Risk
      54
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      54
    term
    Alkaline phosphatase increased
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    NCI CTC Version 4.0
    stats
    1. group Id
      EG000
      num Affected
      35
      num At Risk
      54
    2. group Id
      EG001
      num Affected
      42
      num At Risk
      54
    term
    Alopecia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    NCI CTC Version 4.0
    stats
    1. group Id
      EG000
      num Affected
      41
      num At Risk
      54
    2. group Id
      EG001
      num Affected
      44
      num At Risk
      54
    term
    Anemia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    NCI CTC Version 4.0
    stats
    1. group Id
      EG000
      num Affected
      27
      num At Risk
      54
    2. group Id
      EG001
      num Affected
      21
      num At Risk
      54
    term
    Anorexia
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    NCI CTC Version 4.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      54
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      54
    term
    Anxiety
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    NCI CTC Version 4.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      54
    2. group Id
      EG001
      num Affected
      11
      num At Risk
      54
    term
    Arthralgia
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Investigations
    source Vocabulary
    NCI CTC Version 4.0
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      54
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      54
    term
    Aspartate aminotransferase increased
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    NCI CTC Version 4.0
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      54
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      54
    term
    Back pain
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Eye disorders
    source Vocabulary
    NCI CTC Version 4.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      54
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      54
    term
    Blurred vision
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    NCI CTC Version 4.0
    stats
    1. group Id
      EG000
      num Affected
      10
      num At Risk
      54
    2. group Id
      EG001
      num Affected
      7
      num At Risk
      54
    term
    Cough
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Renal and urinary disorders
    source Vocabulary
    NCI CTC Version 4.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      54
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      54
    term
    Cystitis noninfective
serious Events
  1. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Infections and infestations
    source Vocabulary
    NCI CTC Version 4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      54
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      54
    term
    Abdominal infection
  2. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Immune system disorders
    source Vocabulary
    NCI CTC Version 4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      54
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      54
    term
    Allergic reaction
  3. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    NCI CTC Version 4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      54
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      54
    term
    Anemia
  4. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    NCI CTC Version 4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      54
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      54
    term
    Anorexia
  5. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    NCI CTC Version 4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      54
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      54
    term
    Chest wall pain
  6. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Psychiatric disorders
    source Vocabulary
    NCI CTC Version 4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      54
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      54
    term
    Confusion
  7. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Metabolism and nutrition disorders
    source Vocabulary
    NCI CTC Version 4.0
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      54
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      54
    term
    Dehydration
  8. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    NCI CTC Version 4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      54
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      54
    term
    Diarrhea
  9. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Respiratory, thoracic and mediastinal disorders
    source Vocabulary
    NCI CTC Version 4.0
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      54
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      54
    term
    Dyspnea
  10. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    NCI CTC Version 4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      54
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      54
    term
    Fatigue
  11. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Blood and lymphatic system disorders
    source Vocabulary
    NCI CTC Version 4.0
    stats
    1. group Id
      EG000
      num Affected
      5
      num At Risk
      54
    2. group Id
      EG001
      num Affected
      2
      num At Risk
      54
    term
    Febrile neutropenia
  12. assessment Type
    NON_SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    NCI CTC Version 4.0
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      54
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      54
    term
    Generalized muscle weakness
time Frame
6 years

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Preserved source evidence · Not medical advice