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NCT00295646 · ADVERSE EVENTS

Adverse events

Tamoxifen Versus Anastrozole, Alone or in Combination With Zoledronic Acid · Source last updated 2024-03-15

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
Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.
Other-event reporting threshold
0%

All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.

Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
AZ (Arimidex+Zoledronate)

Study Drugs Arimidex (Anastrozole), Zometa (Zoledronate; zoledronic acid) anastrozole: 1 mg/d zoledronic acid: 4 mg q6m goserelin: 3.6 mg goserelin subcutaneously every 28 days

67 / 450355 / 4509 / 450
TZ (Tamoxifen+Zoledronate)

Study Drugs Nolvadex (Tamoxifen), Zometa (Zoledronate; zoledronic acid) tamoxifen: 20 mg/d zoledronic acid: 4 mg q6m goserelin: 3.6 mg goserelin subcutaneously every 28 days

103 / 450320 / 4507 / 450
AC (Arimidex Control)

Study Drug Arimidex (Anastrozole) anastrozole: 1 mg/d goserelin: 3.6 mg goserelin subcutaneously every 28 days

55 / 453340 / 45318 / 453
TC (Tamoxifen Control)

Study Drug Nolvadex (Tamoxifen) tamoxifen: 20 mg/d goserelin: 3.6 mg goserelin subcutaneously every 28 days

93 / 450290 / 4508 / 450

Group identifiers: EG000: AZ (Arimidex+Zoledronate) · EG001: TZ (Tamoxifen+Zoledronate) · EG002: AC (Arimidex Control) · EG003: TC (Tamoxifen Control)

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
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 10.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      450
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      450
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      453
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      450
      num Events
      0
    term
    Arthralgia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 10.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      450
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      450
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      453
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      450
      num Events
      0
    term
    Bone pain
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Reproductive system and breast disorders
    source Vocabulary
    MedDRA 10.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      450
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      450
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      453
      num Events
      1
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      450
      num Events
      3
    term
    Breast inflammation
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 10.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      450
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      450
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      453
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      450
      num Events
      0
    term
    Cognitive disorder
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA 10.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      450
      num Events
      4
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      450
      num Events
      6
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      453
      num Events
      1
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      450
      num Events
      3
    term
    Cutaneous reaction
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 10.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      450
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      450
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      453
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      450
      num Events
      1
    term
    Diarrhea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    MedDRA 10.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      450
      num Events
      2
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      450
      num Events
      4
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      453
      num Events
      2
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      450
      num Events
      6
    term
    Disease of liver / gallbladder
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 10.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      450
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      450
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      453
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      450
      num Events
      1
    term
    Dizziness
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 10.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      450
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      450
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      453
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      450
      num Events
      1
    term
    Fever
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA 10.1
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      450
      num Events
      8
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      450
      num Events
      4
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      453
      num Events
      4
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      450
      num Events
      6
    term
    Fracture
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 10.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      450
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      450
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      453
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      450
      num Events
      1
    term
    Headache
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 10.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      450
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      450
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      453
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      450
      num Events
      1
    term
    Hemorrhoids

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
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA (10.1)
    stats
    1. group Id
      EG000
      num Affected
      150
      num At Risk
      450
      num Events
      464
    2. group Id
      EG001
      num Affected
      65
      num At Risk
      450
      num Events
      133
    3. group Id
      EG002
      num Affected
      112
      num At Risk
      453
      num Events
      315
    4. group Id
      EG003
      num Affected
      52
      num At Risk
      450
      num Events
      124
    term
    Arthralgia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA (10.1)
    stats
    1. group Id
      EG000
      num Affected
      185
      num At Risk
      450
      num Events
      571
    2. group Id
      EG001
      num Affected
      132
      num At Risk
      450
      num Events
      332
    3. group Id
      EG002
      num Affected
      128
      num At Risk
      453
      num Events
      439
    4. group Id
      EG003
      num Affected
      94
      num At Risk
      450
      num Events
      274
    term
    Bone pain
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Reproductive system and breast disorders
    source Vocabulary
    MedDRA (10.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      450
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      450
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      453
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      450
      num Events
      0
    term
    Breast inflammation
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA (10.1)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      450
      num Events
      16
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      450
      num Events
      6
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      453
      num Events
      11
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      450
      num Events
      0
    term
    Cognitive disorder
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA (10.1)
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      450
      num Events
      19
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      450
      num Events
      7
    3. group Id
      EG002
      num Affected
      18
      num At Risk
      453
      num Events
      30
    4. group Id
      EG003
      num Affected
      19
      num At Risk
      450
      num Events
      28
    term
    Cutaneous reaction
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (10.1)
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      450
      num Events
      17
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      450
      num Events
      21
    3. group Id
      EG002
      num Affected
      11
      num At Risk
      453
      num Events
      13
    4. group Id
      EG003
      num Affected
      10
      num At Risk
      450
      num Events
      13
    term
    Diarrhea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA (10.1)
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      450
      num Events
      29
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      450
      num Events
      14
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      453
      num Events
      12
    4. group Id
      EG003
      num Affected
      13
      num At Risk
      450
      num Events
      19
    term
    Dizziness
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (10.1)
    stats
    1. group Id
      EG000
      num Affected
      98
      num At Risk
      450
      num Events
      262
    2. group Id
      EG001
      num Affected
      82
      num At Risk
      450
      num Events
      179
    3. group Id
      EG002
      num Affected
      93
      num At Risk
      453
      num Events
      258
    4. group Id
      EG003
      num Affected
      70
      num At Risk
      450
      num Events
      156
    term
    Fatigue
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (10.1)
    stats
    1. group Id
      EG000
      num Affected
      46
      num At Risk
      450
      num Events
      51
    2. group Id
      EG001
      num Affected
      34
      num At Risk
      450
      num Events
      38
    3. group Id
      EG002
      num Affected
      11
      num At Risk
      453
      num Events
      13
    4. group Id
      EG003
      num Affected
      9
      num At Risk
      450
      num Events
      11
    term
    Fever
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA (10.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      450
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      450
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      453
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      450
      num Events
      1
    term
    Fracture
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA (10.1)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      450
      num Events
      16
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      450
      num Events
      12
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      453
      num Events
      8
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      450
      num Events
      11
    term
    Hair loss
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA (10.1)
    stats
    1. group Id
      EG000
      num Affected
      85
      num At Risk
      450
      num Events
      231
    2. group Id
      EG001
      num Affected
      59
      num At Risk
      450
      num Events
      117
    3. group Id
      EG002
      num Affected
      63
      num At Risk
      453
      num Events
      163
    4. group Id
      EG003
      num Affected
      59
      num At Risk
      450
      num Events
      155
    term
    Headache
Complete source fields
description
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events (SAEs) reported during treatment phase plus 30 days, and after this period only if the investigator could not preclude a causal link to treatment with Anastrozole. Other adverse events were collected from randomization until the first follow-up visit after the last treatment.
event Groups
  1. deaths Num Affected
    9
    deaths Num At Risk
    450
    description
    Study Drugs Arimidex (Anastrozole), Zometa (Zoledronate; zoledronic acid) anastrozole: 1 mg/d zoledronic acid: 4 mg q6m goserelin: 3.6 mg goserelin subcutaneously every 28 days
    id
    EG000
    other Num Affected
    355
    other Num At Risk
    450
    serious Num Affected
    67
    serious Num At Risk
    450
    title
    AZ (Arimidex+Zoledronate)
  2. deaths Num Affected
    7
    deaths Num At Risk
    450
    description
    Study Drugs Nolvadex (Tamoxifen), Zometa (Zoledronate; zoledronic acid) tamoxifen: 20 mg/d zoledronic acid: 4 mg q6m goserelin: 3.6 mg goserelin subcutaneously every 28 days
    id
    EG001
    other Num Affected
    320
    other Num At Risk
    450
    serious Num Affected
    103
    serious Num At Risk
    450
    title
    TZ (Tamoxifen+Zoledronate)
  3. deaths Num Affected
    18
    deaths Num At Risk
    453
    description
    Study Drug Arimidex (Anastrozole) anastrozole: 1 mg/d goserelin: 3.6 mg goserelin subcutaneously every 28 days
    id
    EG002
    other Num Affected
    340
    other Num At Risk
    453
    serious Num Affected
    55
    serious Num At Risk
    453
    title
    AC (Arimidex Control)
  4. deaths Num Affected
    8
    deaths Num At Risk
    450
    description
    Study Drug Nolvadex (Tamoxifen) tamoxifen: 20 mg/d goserelin: 3.6 mg goserelin subcutaneously every 28 days
    id
    EG003
    other Num Affected
    290
    other Num At Risk
    450
    serious Num Affected
    93
    serious Num At Risk
    450
    title
    TC (Tamoxifen Control)
frequency Threshold
0
other Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA (10.1)
    stats
    1. group Id
      EG000
      num Affected
      150
      num At Risk
      450
      num Events
      464
    2. group Id
      EG001
      num Affected
      65
      num At Risk
      450
      num Events
      133
    3. group Id
      EG002
      num Affected
      112
      num At Risk
      453
      num Events
      315
    4. group Id
      EG003
      num Affected
      52
      num At Risk
      450
      num Events
      124
    term
    Arthralgia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA (10.1)
    stats
    1. group Id
      EG000
      num Affected
      185
      num At Risk
      450
      num Events
      571
    2. group Id
      EG001
      num Affected
      132
      num At Risk
      450
      num Events
      332
    3. group Id
      EG002
      num Affected
      128
      num At Risk
      453
      num Events
      439
    4. group Id
      EG003
      num Affected
      94
      num At Risk
      450
      num Events
      274
    term
    Bone pain
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Reproductive system and breast disorders
    source Vocabulary
    MedDRA (10.1)
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      450
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      450
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      453
      num Events
      1
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      450
      num Events
      0
    term
    Breast inflammation
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA (10.1)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      450
      num Events
      16
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      450
      num Events
      6
    3. group Id
      EG002
      num Affected
      3
      num At Risk
      453
      num Events
      11
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      450
      num Events
      0
    term
    Cognitive disorder
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA (10.1)
    stats
    1. group Id
      EG000
      num Affected
      15
      num At Risk
      450
      num Events
      19
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      450
      num Events
      7
    3. group Id
      EG002
      num Affected
      18
      num At Risk
      453
      num Events
      30
    4. group Id
      EG003
      num Affected
      19
      num At Risk
      450
      num Events
      28
    term
    Cutaneous reaction
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA (10.1)
    stats
    1. group Id
      EG000
      num Affected
      12
      num At Risk
      450
      num Events
      17
    2. group Id
      EG001
      num Affected
      17
      num At Risk
      450
      num Events
      21
    3. group Id
      EG002
      num Affected
      11
      num At Risk
      453
      num Events
      13
    4. group Id
      EG003
      num Affected
      10
      num At Risk
      450
      num Events
      13
    term
    Diarrhea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA (10.1)
    stats
    1. group Id
      EG000
      num Affected
      18
      num At Risk
      450
      num Events
      29
    2. group Id
      EG001
      num Affected
      9
      num At Risk
      450
      num Events
      14
    3. group Id
      EG002
      num Affected
      7
      num At Risk
      453
      num Events
      12
    4. group Id
      EG003
      num Affected
      13
      num At Risk
      450
      num Events
      19
    term
    Dizziness
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (10.1)
    stats
    1. group Id
      EG000
      num Affected
      98
      num At Risk
      450
      num Events
      262
    2. group Id
      EG001
      num Affected
      82
      num At Risk
      450
      num Events
      179
    3. group Id
      EG002
      num Affected
      93
      num At Risk
      453
      num Events
      258
    4. group Id
      EG003
      num Affected
      70
      num At Risk
      450
      num Events
      156
    term
    Fatigue
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA (10.1)
    stats
    1. group Id
      EG000
      num Affected
      46
      num At Risk
      450
      num Events
      51
    2. group Id
      EG001
      num Affected
      34
      num At Risk
      450
      num Events
      38
    3. group Id
      EG002
      num Affected
      11
      num At Risk
      453
      num Events
      13
    4. group Id
      EG003
      num Affected
      9
      num At Risk
      450
      num Events
      11
    term
    Fever
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA (10.1)
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      450
      num Events
      0
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      450
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      453
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      450
      num Events
      1
    term
    Fracture
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA (10.1)
    stats
    1. group Id
      EG000
      num Affected
      9
      num At Risk
      450
      num Events
      16
    2. group Id
      EG001
      num Affected
      8
      num At Risk
      450
      num Events
      12
    3. group Id
      EG002
      num Affected
      6
      num At Risk
      453
      num Events
      8
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      450
      num Events
      11
    term
    Hair loss
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA (10.1)
    stats
    1. group Id
      EG000
      num Affected
      85
      num At Risk
      450
      num Events
      231
    2. group Id
      EG001
      num Affected
      59
      num At Risk
      450
      num Events
      117
    3. group Id
      EG002
      num Affected
      63
      num At Risk
      453
      num Events
      163
    4. group Id
      EG003
      num Affected
      59
      num At Risk
      450
      num Events
      155
    term
    Headache
serious Events
  1. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 10.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      450
      num Events
      1
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      450
      num Events
      1
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      453
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      450
      num Events
      0
    term
    Arthralgia
  2. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Musculoskeletal and connective tissue disorders
    source Vocabulary
    MedDRA 10.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      450
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      450
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      453
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      450
      num Events
      0
    term
    Bone pain
  3. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Reproductive system and breast disorders
    source Vocabulary
    MedDRA 10.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      450
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      450
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      453
      num Events
      1
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      450
      num Events
      3
    term
    Breast inflammation
  4. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 10.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      450
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      450
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      453
      num Events
      0
    4. group Id
      EG003
      num Affected
      0
      num At Risk
      450
      num Events
      0
    term
    Cognitive disorder
  5. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Skin and subcutaneous tissue disorders
    source Vocabulary
    MedDRA 10.1
    stats
    1. group Id
      EG000
      num Affected
      3
      num At Risk
      450
      num Events
      4
    2. group Id
      EG001
      num Affected
      5
      num At Risk
      450
      num Events
      6
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      453
      num Events
      1
    4. group Id
      EG003
      num Affected
      3
      num At Risk
      450
      num Events
      3
    term
    Cutaneous reaction
  6. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 10.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      450
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      450
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      453
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      450
      num Events
      1
    term
    Diarrhea
  7. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Hepatobiliary disorders
    source Vocabulary
    MedDRA 10.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      450
      num Events
      2
    2. group Id
      EG001
      num Affected
      3
      num At Risk
      450
      num Events
      4
    3. group Id
      EG002
      num Affected
      2
      num At Risk
      453
      num Events
      2
    4. group Id
      EG003
      num Affected
      5
      num At Risk
      450
      num Events
      6
    term
    Disease of liver / gallbladder
  8. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 10.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      450
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      450
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      453
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      450
      num Events
      1
    term
    Dizziness
  9. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    General disorders
    source Vocabulary
    MedDRA 10.1
    stats
    1. group Id
      EG000
      num Affected
      2
      num At Risk
      450
      num Events
      2
    2. group Id
      EG001
      num Affected
      1
      num At Risk
      450
      num Events
      1
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      453
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      450
      num Events
      1
    term
    Fever
  10. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Injury, poisoning and procedural complications
    source Vocabulary
    MedDRA 10.1
    stats
    1. group Id
      EG000
      num Affected
      7
      num At Risk
      450
      num Events
      8
    2. group Id
      EG001
      num Affected
      4
      num At Risk
      450
      num Events
      4
    3. group Id
      EG002
      num Affected
      4
      num At Risk
      453
      num Events
      4
    4. group Id
      EG003
      num Affected
      6
      num At Risk
      450
      num Events
      6
    term
    Fracture
  11. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Nervous system disorders
    source Vocabulary
    MedDRA 10.1
    stats
    1. group Id
      EG000
      num Affected
      1
      num At Risk
      450
      num Events
      1
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      450
      num Events
      0
    3. group Id
      EG002
      num Affected
      0
      num At Risk
      453
      num Events
      0
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      450
      num Events
      1
    term
    Headache
  12. assessment Type
    SYSTEMATIC_ASSESSMENT
    organ System
    Gastrointestinal disorders
    source Vocabulary
    MedDRA 10.1
    stats
    1. group Id
      EG000
      num Affected
      0
      num At Risk
      450
      num Events
      0
    2. group Id
      EG001
      num Affected
      0
      num At Risk
      450
      num Events
      0
    3. group Id
      EG002
      num Affected
      1
      num At Risk
      453
      num Events
      1
    4. group Id
      EG003
      num Affected
      1
      num At Risk
      450
      num Events
      1
    term
    Hemorrhoids
time Frame
Maximum observation period per patient for all-cause mortality was 102 months starting with randomization. Reporting period for adverse events started with randomization and lasted until the first follow-up visit after the last treatment.

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Preserved source evidence · Not medical advice