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Safety Profile

Adverse reactions
Serious adverse reactions

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 (%)

Diarrhea^a	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)
Stomatitis^b	58 (16.3)	6 (1.7)	11 (3.1)	0

Fatigue^c

78
(22.0)

5
(1.4)

47
(13.4)

Cutaneous
adverse reactions^d

165
(46.5)

60
(16.9)

38
(10.9)

1
(0.3)

Hyperglycemia^e	51 (14.4)	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

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. ^eHyperglycemia includes PTs of hyperglycemia, blood glucose increased, type 2 diabetes mellitus and diabetes mellitus.

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%)

Learn about the efficacy profile of TRUQAP

Learn about how TRUQAP works

Important safety information for TRUQAP®

Safety Profile

Safety profile for the CAPItello-291 trial

Gastrointestinal disorders

General disorders and administration site conditions

Skin and subcutaneous tissue disorders

Metabolism and nutrition disorders

Serious adverse reactions and discontinuation information

Important safety information for TRUQAP^®