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Safety Profile

Safety profile for the CAPItello-291 trial

Please consult the TRUQAP Product Monograph for a full listing of adverse drug reactions.

Adverse drug reactions occurring in ≥10% (All Grades) of patients

Adverse drug reaction frequencies presented in the table below are those considered to be causally related to treatment based on assessment by the investigator.

System
Organ Class
(SOC)		 TRUQAP + fulvestrant (n=355) Placebo + fulvestrant (n=350)
Adverse reactions All Grades (%) Grade 3-4 (%) All Grades (%) Grade 3-4 (%)

Diarrheaa 239
(67.3)		 33
(9.3)		 46
(13.1)		 0
Nausea 97
(27.3)		 2
(0.6)		 37
(10.6)		 2
(0.6)
Vomiting 56
(15.8)		 5
(1.4)		 9
(2.6)		 2
(0.6)
Stomatitisb 58
(16.3)		 6
(1.7)		 11
(3.1)		 0

Fatiguec 78
(22.0)		 5
(1.4)		 47
(13.4)		 0

Cutaneous
adverse reactionsd		 165
(46.5)		 60
(16.9)		 38
(10.9)		 1
(0.3)

Hyperglycemiae 50
(14.1)		 8
(2.3)		 7
(2.0)		 1
(0.3)
Decreased appetite 38
(10.7)		 1
(0.3)		 8
(2.3)		 1 (0.3)

Adapted from the TRUQAP Product Monograph and data on file1,8

Management of adverse drug reactions
Please refer to the Product Monograph for all recommendations and recommended dose modifications for hyperglycemia, diarrhea, cutaneous and other adverse drug reactions. Management of adverse drug reactions may require temporary dosing interruption, reduction and/or discontinuation of TRUQAP. The dosing reduction recommendations are listed in the Product Monograph. A maximum of 2 dosing reductions are recommended, after which the patient should be discontinued from treatment with TRUQAP. Please see the Dose Modification section for recommended dose modifications.1

MedDRA=Medical Dictionary for Regulatory Activities; PT=MedDRA Preferred Term.
a Diarrhea includes PTs of diarrhea and frequent bowel movements. b Stomatitis includes PTs of stomatitis, aphthous ulcer, lip ulceration, mouth ulceration and mucosal inflammation. c Fatigue includes PTs of fatigue, malaise and asthenia. d Cutaneous adverse reaction includes the PTs of dermatitis allergic, acne, butterfly rash, dermatitis, drug reaction with eosinophilia and systemic symptoms, dry skin, eczema, erythema multiforme, papule, pruritus, rash, rash erythematous, rash follicular, rash macular, rash maculo-papular, rash papular, rash pruritic, skin discoloration, skin fissures, skin hyperpigmentation, skin reaction, skin ulcer, urticaria, rash pustular, purpura, erythema, drug eruption, dermatitis exfoliative generalized. e Hyperglycemia includes PTs of hyperglycemia and blood glucose increased.

Serious adverse reactions and discontinuation information

Serious adverse reactions occurred in 6.2% of patients receiving TRUQAP + fulvestrant.1

Serious adverse reactions reported in ≥1% of patients

Adverse reaction
Cutaneous reactions
Diarrhea
TRUQAP + fulvestrant (%)
3.4%
1.7%

Adapted from the TRUQAP Product Monograph1

Dose reductions and discontinuation rate

Dose reductions
18.6% TRUQAP + fulvestrant
The most frequent (≥2%) leading to dose reductions
  • Diarrhea (7.9%)
  • Cutaneous adverse reactions (6.5%)
Low discontinuation rate reported
10.4% of TRUQAP + fulvestrant patients discontinued due to adverse reactions
The most frequent (≥2%) leading to treatment discontinuation
  • Cutaneous adverse reactions (6.5%)
  • Diarrhea (2.0%)
  • Vomiting (2.0%)
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